Vial supporter for medicament pump

ABSTRACT

Devices and methods for filling a medicament cartridge of a pump, including a user-wearable, ambulatory infusion pump. A device for supporting a medicament cartridge can comprise a body portion resembling a tray, with recesses disposed therein to support one or more of a cartridge body, cartridge tubing, interconnect fitting, and vial adapter. The recesses of the tray may be shaped to correspond to that component intended to be placed in its respective recess so to provide a visual indication to a user how to couple and align the various components necessary to fill the cartridge.

RELATED APPLICATION

The present application claims the benefit of U.S. ProvisionalApplication No. 62/394,806 filed Sep. 15, 2016, which is herebyincorporated herein in its entirety by reference.

FIELD OF THE INVENTION

The present invention relates to medical pumps for delivering medicamentto a patient and, more specifically, to a vial supporter for securelyholding a medicament vial during a cartridge filling process.

BACKGROUND OF THE INVENTION

There are many applications in academic, industrial, and medical fieldsthat benefit from devices and methods that are capable of accurately andcontrollably delivering fluids, such as liquids and gases, that have abeneficial effect when administered in known and controlled quantities.Such devices and methods can be particularly useful in the medical fieldwhere treatments for many patients include the administration of a knownamount of a substance at predetermined intervals.

One category of devices for delivering such fluids is that of pumps thathave been developed for the administration of insulin and othermedicaments for those suffering from both type I and type II diabetes.Some pumps configured as portable infusion devices can providecontinuous subcutaneous medicament injection and/or infusion therapy forthe treatment of diabetes. Such therapy may include, e.g., the regularand/or continuous injection or infusion of insulin into a personsuffering from diabetes and offer an alternative to multiple dailyinjections of insulin by an insulin syringe or an insulin pen. Suchpumps can be ambulatory/portable infusion pumps that are worn by theuser and may use replaceable cartridges. Examples of such pumps andvarious features that can be associated with such pumps include thosedisclosed in U.S. Patent Application Publication Nos. 2013/0053816,2013/0324928 and 2013/0331790, and in U.S. Pat. Nos. 8,287,495,8,573,027 and 8,986,253, each of which is hereby incorporated herein byreference in its entirety.

One type of pump that has been developed is a patch pump, or micro pump.Patch pumps generally are small pumps, typically ambulatory, that arecarried directly on the skin under the patient's clothing. Many suchpumps are situated directly on the injection site such that no tubing isrequired to deliver the insulin and/or other medicament to the patient.Other patch pumps can be positioned on the patient's body with a shortlength of tubing extending to a nearby infusion site. Not unlike othertypes of pumps, but perhaps more typically, patch pumps can be at leastin part disposable, meant to be worn for a period of time such as, e.g.,a day or two, and then discarded and replaced by a new patch pump. Otherpatch pump designs contemplate a disposable component, such as acartridge that contains medicament, and a reusable or durable component.In such configurations, the disposable and durable components may bejoined together by the patient or caregiver in preparation for deliveryof the medicament.

Some pumps, including patch pumps, may include medicament cartridges.Such cartridges may be intended for single use only (and thus intendedto be filled once) while other cartridges may be intended to be refilledone or more times. Embodiments of the invention disclosed herein coverboth such types of cartridge. As such, the terms “fill” and “fillable”should be construed herein to mean cartridges that are intended to befilled once as well as cartridges that are intended to be filled morethan once. Moreover, as used herein, the term “fill” encompasses boththe act of introducing medicament into a cartridge to its maximumcapacity and, in some instances, introducing medicament into a cartridgeto less than its maximum capacity. Likewise, the term “fillable” refersto cartridges for use with embodiments of the invention disclosed hereinthat may be filled to their maximum or to less than their maximumcapacity with medicament. To fill a medicament cartridge, a vial orcontainer of medicament typically is coupled to the cartridge of thepump and medicament is transferred from the container to the cartridge.Existing methods of filling pumps can be awkward for a user (patient orcaregiver) do to many such cartridges including flexible tubingextending from the cartridge body that is not rigid enough to support avial of medicament. Thus, users often must carefully hold the cartridge,the container, and any necessary adapters or couplers, while allowingthe medicament to transfer from the container to the cartridge. Thefilling methods are further complicated if the user must assist thecartridge filling process, such as by pulling a fill rod to drawmedicament into the cartridge.

SUMMARY OF THE INVENTION

Devices and methods for filling a medicament cartridge of a pump,including a user-wearable, ambulatory infusion pump. A device forsupporting a medicament cartridge can comprise a body portion resemblinga tray, with recesses disposed therein to support one or more of acartridge body, cartridge tubing, interconnect fitting, and vialadapter. The recesses of the tray may be shaped to correspond to thatcomponent intended to be placed in its respective recess so to provide avisual indication to a user how to couple and align the variouscomponents necessary to fill the cartridge.

In one embodiment, a device for supporting a medicament cartridge of anambulatory infusion pump during a procedure for filling the medicamentcartridge with a medicament includes a tray having a cartridge end and avial end. A cartridge holder can be defined in the tray body adjacentthe cartridge end, the cartridge holder comprising a recess in the traybody and having a bottom surface and a perimeter shape generallymatching an outer perimeter of a body of the medicament cartridgeconfigured to be retained in the cartridge holder. A fitting holder canbe defined in the tray body adjacent the vial end, the fitting holdercomprising a recess in the tray body configured to retain aninterconnect fitting of the medicament cartridge and having a shapegenerally matching a shape of the interconnect fitting. A tubing holdercan be defined in the tray body, the tubing holder comprising a channelconfigured to retain a tubing section of the medicament cartridge. Invarious embodiments, a vial adapter holder can also be defined in thetray body adjacent the fitting holder at the cartridge end of the traybody, the vial adapter comprising a recess in the tray body configuredto retain a portion of a vial adapter configured to attach to theinterconnect fitting of the medicament cartridge therein.

In another embodiment, a system for filling a medicament cartridge of anambulatory infusion pump with a medicament can include a medicamentcartridge and a cartridge supporter. The medicament cartridge caninclude a cartridge body defining an outer perimeter, a tubing sectionextending from the cartridge body and an interconnect fitting at adistal end of the tubing section. The cartridge supporter is configuredto support the medicament cartridge during a procedure for filling themedicament cartridge with a medicament. The cartridge supporter candefine a tray body having a cartridge end and a vial end and include acartridge holder recess having a perimeter shape generally matching theouter perimeter of the cartridge body, a fitting holder recess having ashape generally matching a shape of the interconnect fitting and atubing holder channel configured to retain the tubing section.

In another embodiment, a method of filling a medicament cartridgeutilizing a device for supporting a cartridge and/or a vial ofmedicament is described. The method can include placing a medicamentcartridge having a cartridge body and a fitting connected to a tubingportion extending from the cartridge body into a cartridge supporterconfigured as a tray. A medicament vial containing a medicament can beconnected to a vial adapter connected to the fitting. The medicamentcartridge can then be filed with the medicament from the medicament vialwith the medicament cartridge in a cartridge holder of the tray. Afterfilling the medicament vial can be disconnected from the vial adapterand the medicament cartridge removed from the tray. The vial adapter canbe disconnected from the fitting and, in various embodiments, themedicament cartridge can be connected to an ambulatory infusion pump andinfusion set for use or a fitting cap inserted into the fitting to storethe cartridge for later use.

In a further embodiment, a device for supporting the cartridge and/or avial of medicament includes a body portion having a means for supportinga tube of the cartridge and a cradle for securely holding a body of thecartridge. The vial supporter may include one or more features that makegrasping the supporter easier. The cradle of the vial supporter mayinclude one or more arms which at least partially surround the cartridgewhen the cartridge is coupled to the vial supporter during a fillingprocedure.

The above summary is not intended to describe each illustratedembodiment or every implementation of the subject matter hereof. Thefigures and the detailed description that follow more particularlyexemplify various embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in considerationof the following detailed description of various embodiments inconnection with the accompanying figures, in which:

FIG. 1 is a perspective view of a vial supporter according to anembodiment of the present invention.

FIG. 2 is a top plan view of the vial supporter of FIG. 1, coupled witha vial adapter, a container of medicament and a fillable cartridge.

FIG. 3 is a perspective view of FIG. 2 without the container ofmedicament.

FIG. 4 is a detail perspective view of the vial supporter of FIG. 3.

FIG. 5 is a perspective view of a fillable cartridge.

FIG. 6 is a perspective view of a vial supporter according to anotherembodiment of the present invention.

FIG. 7 is another perspective view of the vial supporter of FIG. 6.

FIG. 8 is a perspective view of a cartridge and/or vial supporteraccording to another embodiment of the present invention, coupled with avial adapter and a fillable cartridge.

FIG. 9 is a view of the underside of FIG. 8.

FIG. 10 is a detail view of the supporter of FIG. 8.

FIG. 11 is another perspective view of the supporter of FIG. 8.

FIG. 12 is a perspective view of a cartridge and/or vial supporteraccording to another embodiment of the present invention, coupled with avial adapter and a fillable cartridge.

FIG. 13 is an exploded perspective view of the supporter of FIG. 12.

FIG. 14 is a perspective view of the supporter of FIG. 12.

FIG. 15 is a perspective view of a vial adapter according to anembodiment of the invention.

FIG. 16 is another perspective view of the vial adapter of FIG. 15.

FIG. 17 is a cutaway side view of the vial adapter of FIG. 15.

FIGS. 18A-18B are a flowchart depicting a method of filling a cartridgeusing a vial supporter, according to an embodiment of the invention.

FIGS. 19A-19B and 20A-20B are perspective views of a cartridge and/orvial supporter according to another embodiment of the present invention.

FIG. 20C is a partial cross-sectional view of a portion of the cartridgeand/or vial supporter of FIGS. 19A-19B and 20A-20B.

FIG. 21 is a flowchart depicting a method of filling a cartridge using acartridge and/or vial supporter according to an embodiment of thepresent invention.

FIG. 22 is a flowchart depicting a method of filling a cartridge using acartridge and/or vial supporter according to an embodiment of thepresent invention.

FIG. 23 is a flowchart depicting a method of filling a cartridge using acartridge and/or vial supporter according to an embodiment of thepresent invention.

While various embodiments are amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the claimedinventions to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the subject matter as defined bythe claims.

DETAILED DESCRIPTION OF THE DRAWINGS

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

Described herein are devices and methods for securely supportingcomponents associated with fillable cartridges for patch pumps.

Referring to FIGS. 1-4, one embodiment of a system 100 is depicted,which includes a vial supporter 102 a, a cartridge 160, a fill rod 180,an adapter 190, and/or a medicament vial 210. System 100 may includeall, or less than all of the components depicted in FIGS. 1-4. Vialsupporter 102 a can generally include a body portion 104 having a firstend 106, a second end 108, and one or more features 110 to facilitategrasping vial supporter 102 a by a user during a cartridge fillingprocess and provide a guide as to a desired position to grasp supporter102 a. First end 106 includes a cartridge cradle 116 or other suitablemeans configured for receiving a fillable cartridge 160, and one or morearms 118 or other suitable means configured for coupling with andsupporting cartridge 160. Arms 118 are arranged to facilitate easyinstallation and removal of cartridge 160 while also securely retainingcartridge 160 during filling. As depicted in FIGS. 1-4, each of arms 118may be uniquely shaped and sized but in other embodiments arms 118 maybe symmetrically shaped and/or size, either with respect to anindividual arm 118 or between or among two or more arms, in anycombination. A stop 120 may be included to help locate cartridge 160 insupporter 102 a and prevent movement of cartridge 160 toward second end108 during, e.g., a cartridge filling process. Vial supporter 102 a mayalso have one or more features (not pictured) to limit movement ofcartridge 160 towards first end 106 during, e.g., a cartridge fillingprocess (when fill rod 180 described below is moved or pulled towardsfirst end 106).

Second end 108 may include a cradle 112 configured to couple with andsupport a tubing section 166 of cartridge 160. Alternately, cradle 112may be configured to support an interconnect fitting 168 of cartridge160 in addition to, or instead of, tubing section 166. As depicted inFIGS. 1-4, cradle 112 comprises a raised cradle portion defining anaperture or region 113 into which tubing 166 may be snapped or otherwiseput in place. The open area defined by edges 113 of the cradlefacilitates grasping or otherwise accessing the fitting 168 or tubing166 when a user wishes to remove them from vial supporter 102 a. Inaddition to a single cradle 112, multiple cradles may be utilized, andother configurations of element 112 that support and/or hold tubingsection 166 and/or interconnect fitting 168 and facilitate grasping thefitting and tubing are within the scope of the invention.

Vial supporter 102 a is configured to securely retain and supportcartridge 160 such that cartridge 160 can be easily filled. Body 162 ofcartridge 160 is held in cartridge cradle 116 of vial supporter 102 a,while tubing section 166 is held in cradle 112 of vial supporter 102 a.A fill rod 180 is coupleable to cartridge 160, and a vial adapter 190 iscoupleable to interconnect fitting 168 of cartridge 160. Vial adapter190 facilitates connection between a medicament vial 210 and cartridge160. While filling cartridge 160 using vial supporter 102 a, a user neednot grasp or hold vial 210, as vial 210 is sufficiently held in placewith vial supporter 102 a.

In operation, vial supporter 102 a provides a stable and securearrangement of cartridge 160, tubing 166, adapter 190, and vial 210, andprevents any misalignment or disconnection between these componentswhile filling cartridge 160.

Cartridge 160 is depicted in FIG. 5, and includes body 162, a reservoir164, tubing section 166 and interconnect fitting 168. Cartridge 160and/or the embodiments of vial supporters described herein can beconfigured such that reservoir 164 is visible when cartridge 160 iscoupled with a vial supporter, such that a user can determine the levelof medicament in cartridge 160 and/or visually inspect for bubbles.During a filling procedure or method, fitting 168 provides a connectionfor vial 210. During operation of a pump, fitting 168 provides aconnection to a medicament administration set (not depicted). Cartridge160 also includes a port 170 for fill rod 180, as best depicted in FIG.13.

Referring now to FIGS. 6-7, a vial supporter 102 b is depicted. Vialsupporter 102 b includes components similar to those in vial supporter102 a described previously. Thus, vial supporter 102 b can generallyinclude a body portion 104 having a first end 106 and a second end 108.First end 106 includes a cartridge cradle 116 or other suitable meansconfigured for receiving a fillable cartridge 160, and one or more arms118 or other suitable means configured for coupling with and supportingcartridge 160. Arms 118 are arranged to facilitate easy installation andremoval of cartridge 160 while also securely retaining cartridge 160during cartridge filling. As depicted in FIGS. 6-7, each of arms 118 maybe uniquely shaped and sized but in other embodiments arms 118 may besymmetrically shaped and/or sized, either with respect to an individualarm 118 or between or among two or more arms, in any combination. A stop(not pictured) may be included to help locate cartridge 160 in supporter102 b and prevent movement of cartridge 160 toward second end 108 duringa cartridge filling process. Vial supporter 102 b may also have one ormore features (not pictured) to limit movement of cartridge 160 towardsfirst end 106 during, e.g., a cartridge filling process (when fill rod180 is moved or pulled towards first end 106).

Second end 108 may include a cradle 112 configured to couple with andsupport an interconnect fitting 168 of cartridge 160. Alternately,cradle 112 may be configured to support a tubing section 166 ofcartridge 160 in addition to, or instead of, fitting 168. As depicted inFIGS. 6-7, cradle 112 comprises a raised cradle portion defining anaperture or region 113 into which fitting 168 may be snapped orotherwise put in place. The open area defined by edges 113 of the cradlefacilitates grasping or otherwise accessing the fitting 168 or tubing166 when a user wishes to remove them from vial supporter 102 a. Inaddition to a single cradle 112, multiple cradles may be utilized, andother configurations of element 112 that support and/or hold tubingsection 166 and/or interconnect fitting 168 and facilitate grasping thefitting and tubing are within the scope of the invention.

Vial supporter 102 b is configured to securely retain and supportcartridge 160 such that cartridge 160 can be easily filled. Body 162 ofcartridge 160 is held in cradle 116 of vial supporter 102 b, whiletubing section 166 is held in cradle 112 of vial supporter 102 b. A fillrod 180 is coupleable to cartridge 160, and a vial adapter 190 iscoupleable to interconnect fitting 168 of cartridge 160. Vial adapter190 facilitates connection between a medicament vial 210 and cartridge160. While filling cartridge 160 using vial supporter 102 b withmedicament, a user need not grasp or hold vial 210, as vial 210 issufficiently held in place by vial supporter 102 b.

For any of the embodiments depicted herein, fill rod (or plunger handle)180 can generally include a handle portion 182 configured for graspingby a user, a shaft portion 184, and a threaded portion 186 as depictedin, e.g., FIG. 13.

Referring now to FIGS. 8-11, another embodiment of a cartridge and/orvial supporter 102 c is depicted. Supporter 102 c can generally includea tray body 130 having a cartridge end 132 and a vial end 134, acartridge holder 136, a tubing holder 144, and an interconnect fittingholder 150. Tray body 130 is shaped to ease handling during the processof filling a cartridge with medicament and, in some embodiments, isconfigured to be held by a user in a single hand. Cartridge holder 136comprises a recess, channel, cut-out, relief or similar feature intowhich a cartridge 160 may be at least partially placed or nested.Cartridge holder 136 is sized and shaped to snugly receive cartridge160, including having a perimeter shape generally matching orapproximating an outer perimeter shape of the cartridge. Cartridgeholder 136 may also define an aperture or window 140 configured to allowvisual inspection of reservoir 164 when cartridge 160 is placed inholder 136 as well as to aid in removal of the cartridge by allowing theuser to press on that side of the cartridge to urge the cartridge out ofthe cartridge holder. By visually inspecting cartridge 160, eitherthrough window 140 or the opposite, fully exposed side of the cartridge,a user can determine whether there are air bubbles in the cartridge thatneed to be removed. In addition, the cartridge can comprise a clearmaterial in the reservoir area where the medicament is contained andcan, in some embodiments, include graduated markings delineating volumelevels in the reservoir, such that visual inspection can furtherdetermine the volume of medicament in the cartridge. Also included insupporter 102 c is a ring or other similar retention means 142 throughwhich fill rod 180 may be inserted or placed. Ring 142 assists inretaining cartridge 160 securely in place when fill rod 180 is installedbecause in the depicted embodiment cartridge 160 cannot be removed ifthe fill rod extends through the ring and is attached to the cartridge.

Tubing holder 144 is configured to retain and support tubing section 166of cartridge 160, and can generally include a channel or nest 146 andone or more tabs 148. Channel 146 is preferably sized and shaped toprovide a secure fit, such as a “snap” fit, with one or more of areduced diameter portion 169 of interconnect fitting 168 and a portion167 of cartridge 160. To remove tubing 166 from channel 146, a user maypush down on tab 148, thereby flexing the material and opening channel146, allowing tubing 166 to be removed. Interconnect fitting holder 150may comprise a recess or cradle or one or more other configurationsand/or features sized and shaped to receive interconnect fitting 168 ofcartridge 160. Furthermore, interconnect fitting holder 150 can haveadditional features (not shown) to prevent undesirable rotation of theinterconnect fitting 168 when, e.g., a user is detaching interconnectfitting 168 from vial adapter 190 (such as, e.g., by unscrewing). Invarious embodiments, the recess defining interconnect fitting holder 150may be contiguous and/or continuous with the channel 146 defining tubingholder, which in turn may be contiguous and/or continuous with therecess defining cartridge holder. Thus, in some embodiments, a singlecontinuous recess may define all of the respective holders, with avarying outer perimeter that matches the shape of the respectivecomponent held in each of the holders (additionally optionally includingvial adapter holder 151, discussed below with respect to FIGS. 19-20)and/or a varying depth based on the respective component.

Each of cartridge holder 136, tubing holder 144, and interconnectfitting holder 150 is configured to provide a user with the abilityreadily to perform a quick visual and/or tactile confirmation thatcartridge 160 and associated components are properly positioned andaligned before beginning a cartridge filling process. While fillingcartridge 160 using supporter 102 c, a user need not grasp or hold vial210, as vial 210 is sufficiently held in place with supporter 102 c.This results in significant improvement in the user's experience byreducing the complexity and increasing the simplicity of a key aspect ofusing medicament pumps as described herein.

Referring now to FIGS. 12-14, a cartridge and/or vial supporter 102 d isdepicted. Supporter 102 d includes many components similar to thoseassociated with supporter 102 c described previously. Thus, supporter102 d can generally include a tray body 130 having a cartridge end 132and a vial end 134, a cartridge holder 136, a tubing holder 144, and aninterconnect fitting holder 150. Cartridge holder 136 comprises arecess, channel, cut-out, relief or similar feature into which acartridge 160 may be at least partially placed or nested. Cartridgeholder 136 is sized and shaped to snugly received cartridge 160.Cartridge holder 136 may also include an aperture or window 140 which isconfigured to allow visual inspection of reservoir 164 when cartridge160 is placed in holder 136. Also included in supporter 102 d is a ringor other similar retention means 142 through which shaft 184 of fill rod180 may be inserted or placed. Ring 142 cooperates with fill rod 180 toretain cartridge 160 securely in place when fill rod 180 is installed.

Tubing holder 144 is configured to retain and support tubing section 166of cartridge 160, and can generally include a channel or nest 146 andone or more tabs 148. Channel 146 is preferably sized and shaped toprovide a secure fit with tubing 166. To remove tubing 166 from channel146, a user may push down on tab 148, thereby flexing the material andopening channel 146, allowing tubing 166 to be removed. Tabs 148 asshown in FIGS. 12-14 can clip over one or more of an end portion 167 ofthe cartridge 160 and an end portion 169 of the interconnect fitting 168to securely hold one or both components in place. Downward pressure ontabs 148 can release the components secured therein. Interconnectfitting holder 150 may comprise a recess or cradle (which may or may notbe contiguous with channel or nest 146), or other similar configurationwhich is sized and shaped to receive interconnect fitting 168 ofcartridge 160. In some embodiments, the fitting holder 150 can be shapedto prevent turning of the interconnect fitting 168 when it is disposedin the fitting holder 150.

Each of cartridge holder 136, tubing holder 144, and interconnectfitting holder 150 is configured to provide a user with the abilityreadily to perform a quick visual and/or tactile confirmation thatcartridge 160 and associated components are properly positioned andaligned before beginning a cartridge filling process. This results insignificant improvement in the user's experience and reduces thecomplexity and simplicity of a key aspect of using medicament pumps asdescribed herein. While filling cartridge 160 using supporter 102 d, auser need not grasp or hold vial 210, as vial 210 is sufficiently heldin place with supporter 102 d.

Referring now to FIGS. 15-17, an embodiment of a vial adapter 190 isdepicted. This embodiment can generally include a vial end 192, and acartridge end 202, a bore 194 for receiving vial 210, a retentionfeature 196 disposed within bore 194, a needle 198 for puncturing vial210 and allowing fluid such as medicament to flow therethrough, and oneor more reliefs 200. Cartridge end 202 includes a vial adapter fitting204 configured for coupling to the fitting 168 of cartridge 160 and abore 206 which may be straight or tapered so to improve sealing whenvial adapter 190 is coupled with fitting 168. Other profiles of bore206, including combinations of straight and tapered and/or curvedprofiles, may be used as desired. Fitting 204 may be a Luer-typefitting, a proprietary fitting, or other desired style of fitting. Inuse, vial 210 is placed into bore 194, engaging with retention feature196. Reliefs 200 allow vial adapter 190 to flex slightly when vial 210is installed or removed, thus facilitating secure use.

FIGS. 19A-19B and 20A-20B depict another embodiment of a cartridgeand/or vial supporter 102 e. Similar to the embodiment of, e.g., FIGS.8-11, supporter 102 e is configured with a tray body 130 having acartridge end 132 and a vial end 134. Tray body 130 includes cartridgeholder 136 configured to contain a cartridge 160 therein, a tubingholder 144 and a fitting holder 150. Each of these components isconfigured and functions substantially similarly to the embodimentsdescribed above. In addition, tray 130 includes a vial adapter holder151 defined by a recess, channel, cut-out, relief or similar feature atvial end 134 of trail body 130 adjacent fitting holder 150 and adaptedto receive a fitting end 191 of a vial adapter 190. Because fitting end191 of vial adapter 190 is configured to connect to the interconnectfitting 168 of cartridge, vial adapter holder 151 will generally bepositioned adjacent the fitting holder 150 at vial end 134 of tray body130. In some embodiments, vial adapter holder 151 can be formedcontiguously and/or continuously with interconnect fitting holder 150.In various embodiments, vial adapter holder 151 can be provided with aconfiguration that prevents rotation of vial adapter 190 and therebyprevents unscrewing of fitting end 191 of the vial adapter 190 fromcartridge fitting 168 when the components are nested in the tray body130. In the depicted embodiment, fitting end 191 of the vial adapter isprovided with a hexagonal configuration and vial adapter holder 151 hasa corresponding partial-hexagonal shape matching the configuration ofthe fitting end to prevent such rotation, but in other embodiments anyother matching shapes that prevent rotation could be used.

Also in the embodiment depicted in FIGS. 19A-20B, a fitting retentiontab 148 interfaces with interconnect fitting 168 to retain the fittingin the tray body 130. Fitting 168 can be press fit into fitting holder150 to form an audible “snap” fit as described above with fittingretention tab 148 physically engaging fitting 168 to hold fitting 168 infitting holder 150. This physical engagement can then be released bypressing on fitting retention tab 148 to enable removal of fitting 168from fitting holder 150. This embodiment also includes a cartridgeretention tab 149, which can be seen in the partial cross-sectional viewof FIG. 20C. When cartridge 130 is inserted into cartridge holder 136, abottom wall portion 147 of cartridge is seated beneath cartridgeretention tab 149. This prevents direct upward movement of cartridge 160out of cartridge holder 136. Cartridge 160 can be removed by firsttilting the opposite end of cartridge 160 (adjacent the tubing portion144) upward, and then sliding bottom wall portion 147 away fromcartridge retention tab 149. Fitting retention tab or tabs 148, alongwith cartridge holder 136 and cartridge retention tab 149 and/or thecombination of fill rod 180 and ring 142 (in embodiments describedabove), generally prevent both forward and backward movement and upwardmovement of the components contained in tray body 130 during thecartridge filling process.

Still referring to FIGS. 19A-20B, cartridge 160 further includes afitting cap 161. In some embodiments, plug 165 of fitting cap 161 can beinserted onto cartridge fitting 168 by pressing or rotating cap 163 offitting cap 161 after the cartridge has been filled with medicament andremoved from supporter 102 e to seal the cartridge to prevent leakage ofmedicament if the cartridge is going to be stored and not immediatelyconnected to a pump. Supporter 102 e also provides a fitting cap holder153 that includes a recess 155 into which cap 163 of fitting cap 161fits and a slot 157 into which plug 165 of fitting cap 161 is received.A portion of plug 165, as shown in FIG. 19, extends through supporter102 e such that fitting cap 161 can be removed from supporter 102 e by auser pushing down on plug 165 from that side. In prior art systems thatutilize a similar fitting cap, the cap is generally provided loosely inthe system packaging and, as such, can easily fall out and become lost,contaminated, etc. upon opening the packaging. One advantage of having afitting cap holder 153 in the tray body 130 in embodiments of thepresent invention is that when the device is initially removed from thepackaging, the fitting cap 161 is secured to the tray body and cantherefore be both easily located for use and prevented from falling out.

Referring now to FIGS. 18A and 18B, a method 208 for filling amedicament cartridge of an ambulatory, user-wearable infusion pumpaccording to an embodiment of the invention is depicted and described.Generally, the method includes coupling the cartridge to a vialsupporter and to a vial. Example vial supporters suitable for use withsuch a method are depicted in FIGS. 1-4 and 6-7. With the fill rodretracted, air is pushed into the cartridge. The components are thenarranged such that the vial is the highest point, and the fill rod isretracted to draw medicament from the vial into the cartridge. The vialcan be removed from the adapter, and the adapted removed from theinterconnect fitting of the cartridge. The cartridge can then beattached to an infusion set, and the fill rod and vial supporter areuncoupled from the cartridge and placed aside until the cartridge needsto be filled again.

Referring now to FIG. 21, a method 210 for filling a medicamentcartridge of an ambulatory, user-wearable infusion pump according toanother embodiment is depicted and described. Example cartridge and/orvial supporters suitable for use with the depicted method include, forexample, the cartridge and/or vial supporters shown in FIGS. 8-11, 12-14and 19A-20C. Method 210 includes connecting a vial adapter to aninterconnect fitting of a medicament cartridge at step 212, such asshown in, for example, FIG. 13. The cartridge, including a tubingportion extending from cartridge and the interconnect fitting, andconnected vial adapter can then be seated in a supporter configured as atray at step 214 as described above. The tray can include recessedholders defined therein that are sized and shaped to receive thecartridge, tubing portion and interconnect fitting. In some embodiments,the tray also includes a vial adapter holder that retains a portion ofthe vial adapter. In some embodiments, one or more of a portion ofcartridge and a portion of interconnect fitting can create a snap fitwith one or more tabs on tray to aid in retaining those components inthe tray. A fill rod can then be inserted through a portion of the trayand connected to the cartridge at step 216, although in the embodimentdepicted in FIGS. 19A-19B and 20A-20C the fill rod can be insertedeither prior to or after seating the cartridge in the cartridge holder.Such a seated configuration is shown in, for example, FIGS. 8-12 and19-20. In some embodiments, the system may come pre-packaged in thisconfiguration before initial use of the cartridge. When the cartridge isrefilled, steps 212-216 must be repeated.

Once the cartridge is in the above-described filling configuration inthe tray, at step 218 the fill rod can be positioned to set a desiredfill volume. A vial containing the medicament that is to be infused intothe cartridge can then be attached to the vial adapter at step 220,though it should be noted that the vial could alternatively be connectedto the vial adapter at any earlier portion of the method. The cartridgecan then be filled with the desired volume of the medicament at step 222and the vial removed. As further described and depicted in FIGS.18A-18B, filling the cartridge can include depressing the fill rod topush air into the cartridge, then retracting the fill rod to fill thecartridge with the desired amount, and then checking for air bubbles inthe cartridge before removing the vial. In some embodiments, thecartridge can comprise a clear material in the reservoir area where themedicament is contained and the tray can include a rear opening, such asopening 140 described above, to aid in inspecting the cartridge for airbubbles as well as observing the volume of medicament in the cartridge.The cartridge, fill rod and vial adapter can be removed from the tray atstep 224. In some embodiments, the cartridge removal can be aided by oneor more tabs that release portions of the system that were snap fit intothe tray as described above. In embodiments employing a rear opening forvisual inspection of the cartridge, this opening can further aid incartridge removal by providing easy access for the user to press on thecartridge to push it out of the tray. It should be noted that inembodiments such as those depicted in FIGS. 8-14 in which ring 142cooperates with fill rod 180 to retain the cartridge in tray 130, fillrod 180 must first be removed prior to removing the cartridge and vialadapter. Following removal of the cartridge from the tray, the vialadapter can be disconnected from the interconnect fitting at step 226.

The cartridge is now filled and is readied for use by pushing the fillrod so that a drop of medicament such as insulin is visible at the topof the interconnect fitting and an infusion set attached to interconnectfitting at step 228. The fill rod can then be removed at step 230. Thecartridge can now be attached to a user-wearable, ambulatory infusionpump at step 232. Alternatively, if the cartridge is not going to bestored rather than immediately attached to a pump, a fitting cap such asfitting cap 161 can be inserted into interconnect fitting of cartridgerather than attaching the fitting to an infusion set to precludeaccidental leakage of fluid from cartridge.

Referring now to FIG. 22, a method 240 for filling a medicamentcartridge of an ambulatory, user-wearable infusion pump according toanother embodiment is depicted and described. The depicted method issuitable for use with, for example, the cartridge and/or vial supportersshown in FIGS. 8-11, 12-14 and 19A-20C. In this embodiment, tray body130, vial adapter 190 and cartridge 160 (and fill rod 180) are providedto the user pre-assembled. At step 242, the user removes thispre-assembled combination from the product packaging, sets the desiredfill volume with the fill rod at step 243 and connects a medicament vialto the vial adapter at step 244. After pushing air into the medicamentvial with the fill rod at step 245, the cartridge is then filled withmedicament at step 246 as described above and the vial removed from thevial adapter at step 248. The cartridge and vial adapter can then beremoved from the tray at step 250 followed by removal of the vialadapter from the cartridge at step 252. The fill rod is then pushed sothat a drop of medicament such as insulin is visible at the tip of thefitting at step 254 and the fill rod removed from the cartridge at step256 as described above. The filled cartridge can now be attached to thepump or stored for later use at step 258.

FIG. 23 depicts another method 270 for filling a medicament cartridge ofan ambulatory, user-wearable infusion pump according to an embodiment ofthe infusion with a cartridge and/or vial supporter configured as atray. Unlike the method 240 described with respect to FIG. 22 in whichcomponents of the system are provided to the user pre-assembled, in thisembodiment the user must assemble the cartridge components for filling.Such a procedure may occur when a user is refilling a cartridge afterone or more initial uses. At step 272 the vial adapter is connected tothe interconnect fitting of the cartridge and at step 274 the fill rodis connected to the cartridge. This assembly can then be placed into thecartridge tray at step 276. The fill rod can be set for a desired fillvolume at 277 and the medicament vial can be connected to the vialadapter at step 278. Air can be pushed into the medicament vial with thefill rod at step 279 and the cartridge filled with medicament at step280. The medicament vial is then removed from the vial adapter at step282 and the cartridge assembly removed from the tray at step 284. Thefilled cartridge can then be readied for use as described previously byremoving the vial adapter from the interconnect fitting at step 286,pushing the fill rod so that a drop of medicament such as insulin isvisible at the tip of the fitting at step 288 and removing the fill rodat step 290. The filled cartridge is now ready to be attached to a pump(and infusion set) or stored for later use, as described herein, at step292.

Also incorporated herein by reference in their entirety are commonlyowned U.S. Pat. Nos. 8,287,495; 8,408,421 8,448,824; 8,573,027;8,650,937; 8,986,523; 9,173,998; 9,180,242; 9,180,243; 9,238,100;9,242,043; 9,335,910; 9,381,271; 9,421,329; 9,486,171; 9,486,571;9,492,608; 9,503,526; 9,555,186; 9,565,718; 9,603,995; 9,669,160;9,715,327; 9,737,656; and 9,750,871 commonly owned U.S. PatentPublication Nos. 2009/0287180; 2012/0123230; 2013/0053816; 2014/0276419;2014/0276420; 2014/0276423; 2014/0276531; 2014/0276556 2014/0276569;2014/0276570; 2014/0378898; 2015/0073337; 2015/0182693; 2016/0082188;2016/0339172; 2017/0049957; 2017/0142658; 2017/0182248; and 2017/0250971and commonly owned U.S. patent application Ser. Nos. 14/707,851 and15/564,895 and commonly owned U.S. Provisional Application Ser. Nos.61/911,576; 61/920,902; 61/920,914; 61/920,940; 62/139,275; 62/352,164;62/445,041; and 62/545,228.

Further incorporated by reference herein in their entirety are U.S. Pat.Nos. 8,601,465; 8,502,662; 8,452,953; 8,451,230; 8,449,523; 8,444,595;8,343,092; 8,285,328; 8,126,728; 8,117,481; 8,095,123; 7,999,674;7,819,843; 7,782,192; 7,109,878; 6,997,920; 6,979,326; 6,936,029;6,872,200; 6,813,519; 6,641,533; 6,554,798; 6,551,276; 6,295,506; and5,665,065.

Various embodiments of systems, devices, and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the claimed inventions. It should beappreciated, moreover, that the various features of the embodiments thathave been described may be combined in various ways to produce numerousadditional embodiments. Moreover, while various materials, dimensions,shapes, configurations and locations, etc. have been described for usewith disclosed embodiments, others besides those disclosed may beutilized without exceeding the scope of the claimed inventions.

Persons of ordinary skill in the relevant arts will recognize that thesubject matter hereof may comprise fewer features than illustrated inany individual embodiment described above. The embodiments describedherein are not meant to be an exhaustive presentation of the ways inwhich the various features of the subject matter hereof may be combined.Accordingly, the embodiments are not mutually exclusive combinations offeatures; rather, the various embodiments can comprise a combination ofdifferent individual features selected from different individualembodiments, as understood by persons of ordinary skill in the art.Moreover, elements described with respect to one embodiment can beimplemented in other embodiments even when not described in suchembodiments unless otherwise noted.

Although a dependent claim may refer in the claims to a specificcombination with one or more other claims, other embodiments can alsoinclude a combination of the dependent claim with the subject matter ofeach other dependent claim or a combination of one or more features withother dependent or independent claims. Such combinations are proposedherein unless it is stated that a specific combination is not intended.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

For purposes of interpreting the claims, it is expressly intended thatthe provisions of 35 U.S.C. § 112(f) are not to be invoked unless thespecific terms “means for” or “step for” are recited in a claim.

1. A device for supporting a medicament cartridge of an ambulatoryinfusion pump during a procedure for filling the medicament cartridgewith a medicament, comprising: a tray body having a cartridge end and avial end; a cartridge holder defined adjacent the cartridge end in thetray body, the cartridge holder comprising a recess in the tray body,the recess having a bottom surface and a perimeter shape generallymatching an outer perimeter of a body of a medicament cartridgeconfigured to be retained in the cartridge holder; a fitting holderdefined adjacent the vial end in the tray body, the fitting holdercomprising a recess in the tray body that is configured to retain aninterconnect fitting of the medicament cartridge and having a shapegenerally matching a shape of the interconnect fitting; and a tubingholder defined in the tray body, the tubing holder comprising a channelconfigured to retain a tubing section of the medicament cartridge. 2.The device of claim 1, wherein the cartridge holder, the fitting holderand the tubing holder are formed as one continuous recess in the traybody.
 3. The device of claim 1, further comprising a vial adapter holderdefined in the tray body adjacent the fitting holder at the cartridgeend of the tray body, the vial adapter comprising a recess in the traybody that is configured to retain a portion of a vial adapter configuredto attach to the interconnect fitting of the medicament cartridgetherein.
 4. The device of claim 2, wherein the vial adapter holder isconfigured to prevent rotation of the vial adapter when the portion ofthe vial adapter is retained in the vial adapter holder.
 5. The deviceof claim 2, wherein the cartridge holder, the fitting holder, the tubingholder and the vial adapter holder are formed as one continuous recessin the tray body.
 6. The device of claim 1, wherein tray body includesone or more tabs configured to releasably retain the interconnectfitting in the fitting holder.
 7. The device of claim 1, furthercomprising an opening in the bottom surface of the cartridge holder. 8.A system for filling a medicament cartridge of an ambulatory infusionpump with a medicament, comprising: a medicament cartridge having acartridge body defining an outer perimeter, a tubing section extendingfrom the cartridge body and an interconnect fitting at a distal end ofthe tubing section; and a cartridge supporter configured to support themedicament cartridge during a procedure for filling the medicamentcartridge with a medicament, the cartridge supporter defining a traybody having a cartridge end and a vial end and including a cartridgeholder recess having a perimeter shape generally matching the outerperimeter of the cartridge body, a fitting holder recess having a shapegenerally matching a shape of the interconnect fitting and a tubingholder channel configured to retain the tubing section.
 9. The system ofclaim 8, further comprising a vial adapter configured to couple to theinterconnect fitting to facilitate fluid communication between themedicament cartridge and a medicament vial.
 10. The system of claim 9,wherein the cartridge supporter further defines a vial adapter holderrecess configured to retain a portion of the vial adapter therein. 11.The system of claim 10, wherein the vial adapter holder is configured toprevent rotation of the vial adapter when the portion of the vialadapter is retained in the vial adapter holder.
 12. The device of claim10, wherein the cartridge holder, the fitting holder, the tubing holderand the vial adapter holder are formed as one continuous recess in thetray body.
 13. The system of claim 9, further comprising a medicamentvial configured to couple with the vial adapter opposite of theinterconnect fitting.
 14. A method of filling a medicament cartridge ofan ambulatory infusion pump with a medicament, comprising: placing amedicament cartridge having a cartridge body and a fitting connected toa tubing portion extending from the cartridge body into a cartridgesupporter configured as a tray; connecting a medicament vial containinga medicament to a vial adapter connected to the fitting; filling themedicament cartridge with the medicament from the medicament vial withthe medicament cartridge in a cartridge holder of the tray;disconnecting the medicament vial from the vial adapter after fillingthe medicament cartridge; removing the medicament cartridge from thetray; and disconnecting the vial adapter from the fitting.
 15. Themethod of claim 14, further comprising attaching the medicamentcartridge to an ambulatory infusion pump.
 16. The method of claim 14,further comprising inserting a fitting cap into the fitting.
 17. Themethod of claim 14, further comprising connecting the vial adapter tothe fitting.
 18. The method of claim 14, further comprising placing thevial adapter into the tray.
 19. The method of claim 14, furthercomprising: connecting a fill rod to the medicament cartridge; pullingthe fill rod to a desired volume of the medicament to be filled into themedicament cartridge; pushing the fill rod to push air into thecartridge and the medicament vial; pulling the fill rod to the desiredvolume to draw the desired volume of the medicament out of themedicament vial and into the medicament cartridge; and disconnecting thefill rod from the medicament cartridge.
 20. The method of claim 14,wherein removing the medicament cartridge and the vial adapter from thetray includes engaging one or more tabs on the tray that releasablyengage one or more portions of the medicament cartridge.